Liver
ID:AAAE9365
Cooperative Group
Principal Investigator: Dr. Alice Lee
Pediatrics:
AHEP0731: Treatment of Children with All Stages of Hepatoblastoma
This clinical trial will examine hepatoblastoma, a type of cancer that occurs in the liver. It usually occurs in children less than 3 years of age. If left untreated, hepatoblastoma can spread from the liver to other organs in the body such as the lymph nodes and lungs. / /Researchers know that children need different treatments based on the factors associated with the tumor. These factors determine the risk of the tumor coming back. This study will group children as having a very low-risk, low-risk, intermediate-risk or high-risk disease and they will be treated accordingly:Very Low Risk Hepatoblastoma:Some children have a tumor made completely of one type of tumor cell called pure fetal histology (PFH). If the tumor is completely removed it is called Stage 1 disease. If the tumor is Stage 1 AND if it is 100% PFH then treatment will consist of surgery only. These children will not receive chemotherapy.Low Risk Hepatoblastoma:Some children have hepatoblastoma which has been completely removed by surgery but the tumor is not all PFH cells or the tumor is removed but there is a very small amount of tumor cells left in the body. These cases are called Stage 2 hepatoblastoma. A common treatment would be 4 cycles of chemotherapy using 3 drugs called cisplatin, 5-fluorouracil, and vincristine. This treatment is also called C5V.Intermediate Risk Hepatoblastoma:Children with Stage 3 disease include those who cannot have their entire hepatoblastoma tumor removed by surgery. Some tumors are made of a certain kind of tumor cell called small cell undifferentiated (SCU). SCU cells are more aggressive and need more intensive treatment even if the tumor is completely removed. A common treatment includes surgery and chemotherapy, usually with 6 cycles of C5V. If the hepatoblastoma cannot be removed by surgery, a liver transplant may be done after receiving several cycles of chemotherapy.High Risk Hepatoblastoma:Children with Stage 4 disease include those with cancer that has spread from the liver to other parts of the body. There is no good effective treatment for Stage 4 hepatoblastoma or patients with low levels of AFP at diagnosis, but treatment usually includes surgery and chemotherapy. If the hepatoblastoma cannot be removed by surgery, a liver transplant may be done after receiving several cycles of chemotherapy if there is no longer tumor outside of the liver.Approximately 20 patients will be enrolled at Columbia University and 210 patients will be enrolled in the overall study. Participation in the study will last 3years. After treatment, patients will have follow-up examinations and medical tests. Some medical information will be collected up to 10 years after the last patient starts the study.This study will try to learn more about the factors that lead to a good or a poor chance of recovery for children. The goal is to develop effective treatments that will increase the overall success rate and decrease the side effects of the therapy. Please click here to view more information in ClinicalTrials.gov.
For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.
Esophagus, Liver, Other Digestive Organ, Pancreas, Stomach
ID:AAAD0309
Institutional
Principal Investigator: Dr. Yanghee Woo
Adult:
Phase I Trial of Prophylactic Therapy for Peritoneal Recurrence of Foregut Malignancies by Continuous Hyperthermic Peritoneal Perfusion with ELOXATIN (oxaliplatin)
Please click here to view more information in ClinicalTrials.gov.
For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.
Liver
ID:AAAI0577
Institutional
Principal Investigator: Dr. Abby Siegel
Adult:
A Randomized Open-Label Multi-Institution Phase II Study of the Combination of Bevacizumab and Erlotinib Compared to Sorafenib in the First-Line Treatment of Patients with Advanced Hepatocellular Carcinoma (HCC)
This is a randomized open-label phase II research study for subjects who have been diagnosed with hepatocellular carcinoma (HCC, hepatoma, or cancer of the liver). This is a clinical research study of the drugs Sorafenib (Nexavar), Bevacizumab (Avastin) and Erlotinib (Tarceva). The purpose of this study is to test the effectiveness and safety of these two drugs compared to treatment with Sorafenib alone in participants with advanced hepatocellular cancer.Sorafenib is FDA approved for treatment of advanced hepatocellular (liver) cancer. Bevacizumab is FDA approved for treatment of breast, colorectal (cancer that develops in the colon (the longest part of the large intestine) and/or the rectum (the last several inches of the large intestine before the anus), and lung cancer. Erlotinib is FDA approved for treatment of pancreatic and lung cancer. The combination of Bevacizumab and Erlotinib for treatment of advanced hepatocellular cancer is investigational, meaning it is not FDA approved. Please click here to view more information in ClinicalTrials.gov.
For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.
Bones and Joints, Brain and Nervous System, Liver, Lymphoid Leukemia, Myeloid and Monocytic Leukemia, Soft Tissue
ID:AAAI1361
Cooperative Group
Principal Investigator: Dr. Alice Lee
Pediatrics:
ADVL0921: A Phase II Study of MLN8237 (IND# 102984), a Selective Aurora A Kinase Inhibitor
in Children with Recurrent/Refractory Solid Tumors and Leukemias
This is a Phase II single-arm study of a single agent, MLN8237 to evaluate efficacy inpediatric patients with relapsed or refractory solid malignancies or acute leukemias (ALLand AML). As a small molecule inhibitor of aurora A kinase, MLN8237 has demonstrated substantial anti-tumor activity in preclinical pediatric investigations as well as good tolerability and efficacy in adult and pediatric Phase I investigations. Eligible patients will receive oral MLN8237, 80 mg/m2/dose (as enteric-coated tablets), once daily for 7 days, followed by a 14-day rest period. Patients will be closely monitored by clinical and laboratory evaluations for adverse events. Objective evaluations for response using appropriate imaging studies or bone marrow evaluations will occur after 2 cycles of MLN8237, and again after every other treatment cycle for the first year. In the absence of progressive disease or severe toxicity, the drug may be continued for up to 2 years. 6 patients will be treated at Columbia University and about 190 people will take part in this study overall. Please click here to view more information in ClinicalTrials.gov.
For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.
Kidney, Liver, Soft Tissue, Thyroid
ID:AAAJ4351
Cooperative Group
Principal Investigator: Dr. Alice Lee
Pediatrics:
ADVL1121: A Phase II Study of the Raf Kinase and Receptor Tyrosine Kinase Inhibitor Sorafenib
(IND# 69896) in Children and Young Adults with Relapsed/Refractory Rhabdomyosarcoma, Wilms
Tumor, Hepatocellular Carcinoma, and Papillary Thyroid Carcinoma
This is a phase II, multi-center study of Sorafenib, an agent that acts as a control in tumor growth. The purpose of this study is to determine the response rate to as well as evaluate the toxicities of Sorafenib in children and young adults with relapsed (cancers that have come back after being treated before) Rhabdomyosaroma, Wilma Tumor, Hepatocellular Carcinoma, and Papillary Thyroid Carcinoma. Sorafenib will be given every 12 hours as tablets. The therapy will last up to 28 days and the doctor may ask you to visit after to complete follow-up tests. Participants can receive up to 24 cycles of therapy continuously. There will be about 80 patients participating in this study overall and about 6 will be treated at Columbia University Medical Center. The study treatment is considered experimental because it is not approved by the United States (US) Food and Drug Administration (FDA) for treating children and young adults with solid tumors. Please click here to view more information in ClinicalTrials.gov.
For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.
Liver
ID:AAAI9206
Industry
Principal Investigator: Dr. Abby Siegel
Adult:
A Randomized, Placebo-controlled, Double-blind, Multicenter Phase II Trial of Intravenous GC33 at 1600 mg Q2W in Previously Treated Patients with Unresectable Advanced or Metastatic Hepatocellular Carcinoma (HCC)
This is a clinical research study involving an investigational drug called GC33 (also known as RO5137382. The purpose of this study is to find out if GC33 can help stop the growth and spread of cancer cells in subjects with unresectable advanced or metastatic hepatocellular carcinoma (HCC) whose disease has progressed after previous treatment(s) or who have been intolerant to previous treatment(s), and to see if the drug may cause any side effects. GC33 has not been approved by the Food and Drug Administration (FDA) to treat this disease. It is a monoclonal antibody which means it is a naturally produced protein that has been designed by scientists to target a particular type of cells (in this case liver tumor cells) that carry on their surface the protein recognized by GC33, called Glypican-3 (GPC-3). In animals, GC33 has been shown to limit tumor growth (cancer) by binding to GPC-3 on liver tumor cells and induce tumor cell destruction, this suggests that GC33 may be useful for liver cancer treatment in humans. Please click here to view more information in ClinicalTrials.gov.
For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.
Liver
ID:AAAK7952
Industry
Principal Investigator: Dr. Abby Siegel
Adult:
A Phase 2 Study of SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC) Subjects Who Failed Prior Treatments with Sorafenib
This is a Phase 2 study of the investigational drug SGI-110 for the treatment of hepatocellular carcinoma (HCC), a type of advanced liver cancer, after treatment with Sorafenib has failed. This study is being conducted to evaluate the safety, tolerability, and effectiveness of SGI-110 in HCC, as well as any benefits in subjects whose cancer progressed after treatment with Sorafenib. Subjects will be asked to provide samples of their blood and tumor tissue to measure tolerability and response to SGI-110. These samples will provide the investigators further information about the study drug to help patients with advanced liver cancer in the future. Each treatment cycle will last 28 days. Subjects will have three weeks between each 5 day treatment with SGI-110. Cycles will continue as long as the subject is tolerating SGI-110 and wishes to continue. Treatment will end if the cancer progresses again or if Principal Investigator decides that it is no longer in the subject's best interest to continue. About 46 patients will be enrolled in this study, with about 8 at Columbia University Medical Center.
For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.
Liver
ID:AAAJ9252
Cooperative Group
Principal Investigator: Dr. Abby Siegel
Adult:
PHASE III RANDOMIZED STUDY OF SORAFENIB PLUS DOXORUBICIN VERSUS SORAFENIB IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA (HCC)
Hepatocellular carcinoma is the fifth most common cancer worldwide and the third leading cause of cancer death. Currently, the only curative therapies for HCC are surgery and liver transplantation; thus, and urgent need exists for effective therapies that will improve survival in advanced HCC.Sorafenib is an oral agent targeted multi-kinase inhibitor that is approved by the FDA for treatment of patients with advanced HCC and is the new standard of care for this population. Research findings suggest that combining sorafenib with doxorubicin chemotherapeutic agent may result in a synergistic effect, such that the combination of these drugs is more effective than either drug individually. This study will test this hypothesis by comparing the outcomes of patients receiving both agents with patients receiving standard of care (sorafenib alone).In this study, eligible participants will be stratified by extent of disease, and then randomized with equal probability to one of the study's treatment arms. All participants will be asked to participate in optional sub-studies with imaging, biomarkers, and pharmacogenomics. Up to 480 adult subjects will be enrolled, of which 20 will be from Columbia University Medical Center. Please click here to view more information in ClinicalTrials.gov.
For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.
| 
